Table A. Description of included studies
Study
Esteem
Barbara et al
(2009)(1) &
(2011)(2)
Design
Design: retrospective, pre/post
Setting: single academic center
Country: Italy
Comparator: preoperative unaided
Modifications: None
Length of F/U: NR
Chen et al
(2004)(3)
Design: single arm trial
Setting: multicenter
Country: USA
Comparator: preoperative unaided &
the patient’s “best-fit” HA
Modifications: None
Length of F/U: 2 months
Kraus et al
(2011)(4)
Design: single arm trial
Setting: multicenter (3 centers)
Country: USA
Patients
Number: 18 entered & completed
Sex: NR
Age: NR
Type of HL: sensorineural, moderate to severe
Pre-op unaided threshold: mean AC 70dB
Inclusion: consecutive patients with moderate to
severe sensorineural hearing loss implanted with the
Esteem
Number: 7 entered & completed
Sex: 5 male, 2 female
Age: mean 64.4, range 42 – 88 years
Type of HL: sensorineural, mild to severe
Pre-op unaided threshold: NR
Inclusion:
1. age > 18 years
2. mild to severe SNHL between 500 – 4000Hz
3. implanted ear equal or worse than contralateral
4. pure tone AC thresholds between 35 – 85 dB form
500 – 4000Hz
5. use of best fit HA for 4 hrs/day x 3 months
6. normal middle ear & Eustachian tube
7. adequate space for implant, determined by CT
scan
8. speech discrimination ≥60%
9. psychologically & emotionally stable with realistic
expectations
Exclusion:
1. conductive, retrocochlear or central auditory
disorders
2. fluctuation in HL > 15 dB
3. physical &/or emotional disorders prohibiting
testing
4. unable to complete F/U
5. hx of post-adolescent chronic middle ear
infections
6. inner ear disorders
7. hx of otitis externa or eczema
Number: 57 entered & completed
Sex: 38 male, 19 female
Age: mean 52.9, range 18-77.2 years
Outcome Measures
Quality
1. Functional gain
2. Threshold levels
3. Speech recognition @ 60 or
75dB
4. Glasgow Benefit Inventory
5. Client Oriented Scale of
Improvement
Oxford level of evidence:
IV
1. Functional gain
2. Threshold levels
3. Speech reception
4. Speech recognition
- in quiet using CID-W22 word
lists @ 50dB
- in quiet & in 65dB noise using
HINT
5. APHAB
6. Adverse events
Oxford level of evidence:
IV
1. Functional gain
2. Threshold levels using warble
tones & pure tones
Oxford level of evidence:
IV
Comparator: preoperative unaided,
patients “walk-in” HA
Modifications: None
Length of F/U: 12 months
Maurer &
Savvas
Design: single arm trial
Setting: single academic center
Type of HL: sensorinueral, mild to severe
Pre-op unaided threshold: mean AC 63dB
Inclusion:
1. age ≥18 years
2. stable bilateral mild to severe SNHL
3. thresholds from 30-100dB from 0.5 – 4kHz
4. ABG ≤10dB @ 4/5 frequencies
5. word recognition ≥40% @ SRT +40dB
6. normal tympanic membrane, middle ear anatomy
& Eustachian tube
7. appropriately fitted HA use for ≥4hrs/day x 3
months or 1 month for adjusted aid
8. CT showing adequate space for implant
9. English speaking
10. ability to undergo general anesthetic
11. ability & willingness to comply with study
protocol
Exclusion:
1. pregnancy
2. chronic staphylococcal skin infection
3. history of post-adolescent chronic middle ear
infections, inner ear disorders, vertigo, mastoiditis,
or endolymphatic hydrops
4. fluctuating AC or BC thresholds >15dB in either
direction in past 2 years @ ≥2 frequencies between
0.5 – 4kHz
5. cholesteatoma or other destructive middle ear
disease
6. retrocochlear or central auditory disorders
7. psychological, developmental or
physical/emotional disorder preventing F/U
8. disabling tinnitus requiring treatment
9. history of keloid formation
10. hypersensitivity to silicone, polyurethane,
stainless steel, titanium or gold
11. pre-existing medical conditions such as diabetes
mellitus that is not well controlled or life expectancy
≤2 years
12. small mastoid of narrow facial recess
13. unable to adequately preform audiometric
testing
14. history of sudden onset HL of unknown cause
Number: 10 entered & completed
Sex: NR
3. Speech reception threshold
using CD spondee word list
4. Speech recognition @ 50dB
5. Self-assessment QoL
questionnaire
6. Adverse events
1. Functional gain
2. Speech recognition using
Oxford level of evidence:
IV
(2010)(5)
Country: Germany
Comparator: hearing aids
Modifications: None
Length of F/U: 3-40 months
Age: NR
Type of HL: sensorineural & mixed
Pre-op unaided threshold: NR
Inclusion: consecutive patients implanted with the
Esteem
monosyllabic words @ 65dB
(reports range only)
3. APHAB
4. Adverse events
Memari et al
(2011)(6)
Design: single arm trial
Setting: single academic center
Country: Iran
Comparator: preoperative unaided
Modifications: None
Length of F/U: mean 29.4, range 19-40
months
1. Threshold levels
2. Speech recognition
3. Self-assessment QoL
questionnaire
4. Adverse events
Oxford level of evidence:
IV
Murali et al
(2009)(7)
Design: retrospective case series
Setting: single academic center
Country: India
Comparator: preoperative unaided
Modifications: None
Length of F/U: NR
Number: 10 entered & completed
Sex: 3 male, 7 female
Age: mean 32.7 years
Type of HL: sensorineural, moderate to severe
Pre-op unaided threshold: mean AC 65.6dB
Inclusion:
1. age ≥18 years
2. moderate to severe nonfluctating SNHL from 0.5 –
4kHz
3. better or equal hearing in non-implanted ear
4. healthy middle ear with normal anatomy
5. speech discrimination score >50%
6. stable psychological & emotional condition
Exclusion: diabetes mellitus, connective tissue
disorders, chronic otitis media & external otitis
Number: 3 entered & completed
Sex: 2 male, 1 female
Age: mean 28.7, range 22-38 years
Type of HL: sensorineural, postlingual
Pre-op unaided threshold: mean AC 67dB
Inclusion:
1. age ≥ 18 years
2. willing & able to comply with F/U for 1 year,
understand test procedures & use of Esteem
3. mild to severe SNHL
4. Pure tone thresholds from 25 – 90dB @ 0.5- 4kHz
5. ABG ≤10dB @ 4/5 frequencies from 0.5-4kHz
6. unaided word recognition ≥60% @ SRT + 40dB
7. current user of properly functioning &
appropriately fit HA
8. normally functioning Eustachian tube
9. normal tympanic membrane & middle ear
anatomy with intact ossicular chain
1. Threshold levels
2. Speech recognition for words
& sentences
3. Adverse events
Oxford level of evidence:
IV
Number: 8 entered & completed
Sex: 7 male, 1 female
Age: mean 46.4, range 34-66 years
1. Functional Gain
2. Threshold levels
3. Speech recognition using
Oxford level of evidence:
IV
Carina
Bruschini et al
(2009)(8) &
(2010)(9)
Design: retrospective, pre/post
Setting: single academic center
Country: Italy
Comparator: preoperative and
postoperative unaided
Modifications: FMT to incus, stapes, or
titanium ball
Length of F/U: mean 16.9, range 12-21
months
Deveze et al
(2010)(10)
Jenkins et al
(2007)(11) &
(2008)(12)
Lefebvre et al
(2009)(13)
Design: retrospective, case report
Setting: single academic center
Country: Italy
Comparator: hearing aid
Modifications: implant coupled to
footplate, concurrent reconstruction
of external ear canal
Length of F/U: 6 months
Design: single arm trial
Setting: multicenter, general &
academic
Country: USA
Comparator: pre-surgery unaided &
with patient’s own HA
Modifications: None
Length of F/U: 12 months
Design: single arm trial
Setting: multicenter (4 centers)
Country: Belgium, France
Comparator: preoperative &
postoperative unaided
Modifications: attached to round
window
Length of F/U: 12 months
Type of HL: sensorineural or mixed, moderate to
severe, postlingual
Pre-op unaided threshold: mean AC 63.44 (range 5568.75)
Inclusion: consecutive patients implanted with the
Carina
Exclusion:
1. vestibular or osteo-degenerative disorders
2. nonorganic hearing loss
3. central auditory nervous system disorder
4. prelinguistic onset of hearing loss
Number: 1 entered & completed
Sex: 1 female
Age: 63 years
Type of HL: mixed, moderate, postlingual
Pre-op unaided threshold: NR
Inclusion: Not applicable
disyllabic words @ 65dB
4. APHAB
5. Adverse events
1. Functional gain
2. Speech recognition @ 65dB
3. Speech reception threshold
(SRT50)
4. Adverse events
Oxford level of evidence:
IV
Number : 20 entered & completed
Sex: 10 male, 10 female
Age: mean 62.8, range 31.6 – 82 years
Type of HL: sensorineural, moderate to severe, post
lingual
Pre-op unaided threshold: NR
Inclusion:
1. Adults with bilateral moderate to severe HL (PTA
40-80dB)
2. Stable , non-fluctuant HL
3. NU-6 scores >40% @ 80 dB
4. Experience with HA x 3 months
Exclusion: Concomitant disease (ex. retrocochlear HL
or otitis media)
Number: 6 entered & completed
Sex: NR
Age: NR
Type of HL: mixed, moderate to severe
Pre-op unaided threshold: NR
Inclusion: adults (> 18 years old) with stable mixed
hearing loss
Exclusion:
1. retrocochlear, central auditory or functional
components to hearing loss
2. medical contraindications to surgery or MEI
1. Threshold levels
2. Speech recognition:
- in quiet using CNC words &
phenomes
-in 65dB noise using HINT
3. APHAB
4. Self-assessment QoL
questionnaire
5. Adverse events
Oxford level of evidence:
IV
1. Functional gain
2. Threshold levels
3. Speech recognition of
disyllabic words in French @ 65
dB
4. APHAB
5. Adverse events
Oxford level of evidence:
IV
Martin et al
(2009)(14)
Design: retrospective, pre/post
Setting: multicenter, 7 academic
centers
Country: France, Belgium, Spain
Comparator: preoperative unaided
Modifications: prosthesis on fascia
graft on round window
Length of F/U: 2 years
Neumann et al
(2010)(15)+
Design: retrospective, pre/post
Setting: multicenter (2 academic
centers)
Country: Germany
Comparator: preoperative unaided
Modifications: None
Length of F/U: NR
Design: retrospective cohort
Setting: single academic center
Country: France
Comparator: VSB, semi-implantable
MET, preoperative unaided
Modifications: NR
Length of F/U: mean 1.9, range 1-4
years
Design: single arm trial
Setting: single academic center
Country: Germany
Comparator: preoperative unaided
Modifications: malleus-incus complex
was removed & prosthesis attached to
stapes
Length of F/U: ≥3 months
Design: prospective, pre/post
Setting: single academic center
Country: China
Comparator: postoperative unaided
Rameh et al
(2010)(16)
Siegert et al
(2007)(17)
Tong et al
(2009)(18)+
3. unrealistic expectations
Number: 11 entered & completed
Sex: 4 male, 7 female
Age: mean 50.8, range 35-71 years
Type of HL: mixed, moderate to severe
Pre-op unaided threshold: mean AC 77.8dB (range
52-100), mean BC 39dB (range 17.5-62.5)
Inclusion:
1. Consecutive patients
2. Carina placed on round window
3. Stable mixed or conductive hearing loss
Exclusion:
1. signs or symptoms of retrocochlear, central
auditory, or functional components
2. medical contraindications to surgery
3. unrealistic expectations
Number: 6 entered & completed
Sex: 2 male, 4 female
Age: range 38-70 years
Type of HL: sensorineural
Pre-op unaided threshold: NR
Inclusion: consecutive patients implanted with the
Carina
Number: 18 Carina entered, 10 completed
Sex: 5 male, 5 female
Age: mean 64, range 46-84
Type of HL: sensorineural, moderate to severe
Pre-op unaided threshold: mean AC 69.3dB
Inclusion: consecutive patients implanted with the
VSB, semi-implantable MET, or Carina
1. Thresholds levels
2. Speech recognition in quiet
using Fournier lists of Spanish
words @ 65 dB
3. APHAB
4. Adverse events
Oxford level of evidence:
IV
1. Functional gain
2. Threshold levels
3. Speech recognition
Oxford level of evidence:
IV
1. Functional gain
2. Threshold levels
3. Speech reception threshold
(SRT50) using disyllabic words
4. Self-assessment QoL
questionnaire
5. Adverse events
Oxford level of evidence:
IIb
Number: 5 entered & completed
Sex: 4 male, 1 female
Age: mean 31.4, range 18-40 years
Type of HL: conductive, prelingual
Pre-op unaided threshold: mean AC 72dB
Inclusion: patients with hearing loss due to
congenital auricular atresia
1. Functional gain
2. Threshold levels
3. Speech reception using
Freiburger monosyllables
4. Adverse events
Oxford level of
evidence: IV
Number: 3 entered & completed
Sex: NR
Age: NR
Type of HL: moderate to severe
1. Functional gain
Oxford level of
evidence: IV
Modifications: NR
Length of F/U: > 12 months
Pre-op unaided threshold: NR
Inclusion: adults with bilateral moderate to severe
hearing loss
Tringali et al
Design: retrospective, case report
Number: 1 entered & completed
1. Functional gain
Oxford level of
(2008)(19)
Setting: single academic center
Sex: 1 male
2. Threshold levels using pure
evidence: IV
Country: France
Age: 14 years
tones
Comparator: preoperative unaided
Type of HL: conductive, severe
3. Speech reception threshold
Modifications: MEI & prosthesis
Pre-op unaided threshold: mean AC 70dB
(SRT50)
attached to stapes footplate
Inclusion: single patient with Franceschetti syndrome 4. Speech recognition
Length of F/U: 2 months
and bilateral conductive hearing loss, unable to wear 5. Adverse events
a BAHA
Tringali et al
Design: retrospective, case report
Number: 1 entered & completed
1. Functional gain
Oxford level of
(2009)(20)
Setting: single academic center
Sex: 1 female
2. Threshold levels using pure
evidence: IV
Country: France
Age: 48 years
tones
Comparator: postoperative unaided
Type of HL: mixed, severe
3. Speech recognition
Modifications: transducer attached to
Pre-op unaided threshold: mean AC 80dB
round window
Inclusion: single case of mixed hearing loss & chronic
Length of F/U: 15 months
irritation of external ear
HL: hearing loss, NR: not reported, F/U: follow-up, MEI: middle ear implant, AC: air conduction, BC: bone conduction, HA: hearing aid, ABG: air bone gap, SRT: speech reception
threshold, APHAB: Abbreviated Profile of Hearing Aid Benefit
+
Data extracted from abstract only
Table B. Excluded studies
Study
Jiang et al (2004)(21)
Kontorinis et al (2010)(22)
Saiki et al (1990)(23)
Saiki et al (1990)(24)
Snik et al (2006)(25)
Snik et al (2007)(26)
Stieve et al (2009)(27)
Tringali et al (2010)(28)
Verhaegen et al (2008)(29)
Zenner & Jorge (2010)(30)
Main reasons for exclusion
Did not report outcomes of interest
Did not report outcomes of interest
Did not include the devices being assessed
Did not include the devices being assessed
Did not include the devices being assessed
Did not include the devices being assessed
Did not include the devices being assessed
Did not include the devices being assessed
Did not include the devices being assessed
Review article without primary data
Table C. Adverse events reported
Study
Esteem
Chen et al
(2004)(3)
Kraus et al
(2011)(4)
Maurer &
Savvas (2010)(5)
Memari et al
(2011)(6)
Murali et al
(2009)(7)
Total (reported)
Carina
Bruschini et al
(2009)(8) &
(2010)(9)
Deveze et al
(2010)(10)
Jenkins et al
(2007)(11) &
(2008)(12)
Lefebvre et al
(2009)(13)
Martin et al
(2009)(14)
Rameh et al
(2010)(16)
Siegert et al
(2007)(17)
Tringali et al
(2008)(19)
Total (reported)
N
Device
malfunction
or failure
Device
extrusion
or
migration
Damage
to TM
Vertigo or
dizziness
Decrease
in
residual
hearing
Facial
weakness
Taste
disturbance
or chorda
tympani
damage
Pain
or
headache
7
2(28.6%)
0
0
0
NR
0
0
2(28.6%)
57
0
0
0
11(19.3%)
NR
4(7.1%)
25(43.9%)
15(26.3%)
10
1(10%)
0
0
0
NR
0
0
10
1(10%)
0
0
0
NR
2(20%)
3
0
0
0
0
NR
87
4(4.6%)
0
0
11(12.6%)
8
2(25%)
1(12.5%)
0
1
0
0
20
9(45%)
6
Wound
Infection
Minor
Skin
Reaction
Sensation
of aural
fullness
Skin
lacerations
Insufficient
gain
Otitis
or effusion
0
1(14.3%)
0
0
0
4(57.1%)
4(57.1%)
4(57.1%)a
2(3.5%)
0
0
0
4(7.1%)
18(31.6%)
44(77.2%)b
0
10
(17.5%)
0
0
0
0
0
0
0
0
1(10%)
1(10%)
0
0
0
0
0
0
0
2(20%)c
1(33.3%)
0
0
0
0
0
0
0
0
0
0
NR
7(8.0%)
26(29.9%)
18(20.7%)
10(11.5%)
3(3.4%)
0
0
0
8(9.2%)
22(25.3%)
50(57.5%)
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
3(15%)
0
1(5%)
4(20%)
0
0
0
1(5%)
0
0
2(10%)
0
0
3(15%)
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
11
1(9.1%)
0
0
1(9.1%)
0
0
0
0
1(9.1%)
2(18.2%)
0
0
0
0
0
0
16
0
0
0
0
0
0
0
2(12.5%)
0
0
0
0
0
0
0
0
5
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1(100%)d
68
12(17.6%)
4(5.9%)
0
2(2.9%)
4(5.9%)
0
0
2(2.9%)
2(2.9%)
2(2.9%)
0
2(2.9%)
0
0
3(4.4%)
1(1.5%)
TM: tympanic membrane
a
includes: headache, ear pain, leg pain
miscellaneous events which are not described
c
1 excessive bone growth in the middle ear & 1 fibrosis requiring revision surgery
d
hematoma requiring evacuation
b
Tinnitus
Other
Table D1. Functional gain
Study
Esteem
Barbara et al (2009)(1) & (2011)(2)
Chen et al (2004)(3)
Kraus et al (2011)(4)
Maurer & Savvas (2010)(5)
Memari et al (2011)(6)
Murali et al (2009)(7)
Carina
Bruschini et al (2009)(8) &
(2010)(9)
Deveze et al (2010)(10)
Jenkins et al (2007)(11) &
(2008)(12)
Lefebvre et al (2009)(13)
Martin et al (2009)(14)
Neumann et al (2010)(15)
Rameh et al (2010)(16)
Siegert et al (2007)(17)
Tong et al (2009)(18)
Tringali et al (2008)(19)
Tringali et al (2009)(20)
Hearing Aids
Chen et al (2004)(3)
Deveze et al (2010)(10)
Jenkins et al (2007)(11) &
(2008)(12)
Kraus et al (2011)(4)
Maurer & Savvas (2010)(5)
Type of hearing
loss
Severity of hearing
loss
Device type
SNHL
SNHL
SNHL
SNHL, MHL
SNHL
SNHL
moderate-severe
mild-severe
mild-severe
NR
moderate-severe
NR
NR
NR
Esteem SP
NR
NR
NR
SNHL, MHL
moderate-severe
MHL
SNHL
Mean gain
(dB)
Gain by frequency in kHz (dB)
0.25 0.5 1
1.5 2
3
4
6
8
18
5
54
10
10
1
22
17
18.8
33
11.6
26.3
12
10
18
18
22
25
34
50
NR
8
26.4
-
-
-
moderate
moderate-severe
NR
NR
1
20
31.8
9.3
25
2
30
0
25
10
MHL
MHL
SNHL
SNHL
CHL
NR
CHL
MHL
moderate-severe
moderate-severe
NR
moderate-severe
NR
moderate-severe
severe
severe
NR
NR
NR
NR
NR
NR
NR
NR
6
11
6
10
5
3
1
1
20.8
29
26
17.7
33.1
35.4
29
39
9
29
35
20
16
28
25
25
SNHL
mild-severe
5
20
-
MHL
SNHL
moderate
moderate-severe
patient’s “bestfit”
patient’s own
patient’s own
1
20
10.6
15.8
SNHL
SNHL, MHL
mild-severe
NR
patient’s own
patient’s “bestfit”
57
10
17
14.2
SNHL: sensorineural hearing loss, MHL: mixed hearing loss, CHL: conductive hearing loss, NR: not reported
N
-
35
41
38
25
37
-
19
35
29
10
-
6
9
-
-
-
-
-
25
18
40
15
25
7
40
12
45
10
-
28
37
35
50
-
24
35
25
50
36
25
-
13
35
50
32
-
16
-
-
-
-
-
-
-
-
-
10
7
25
9
20
18
10
25
5
25
0
20
10
15
5
7
-
-
11
8
19
15
20
-
18
16
20
19
10
-
-
Table D2: Speech reception
Study
Esteem
Chen et al
(2004)(3)
Kraus et al
(2011)(4)
Carina
Deveze et al
(2010)(10)
Rameh et al
(2010)(16)
Siegert et al
(2007)(17)
Tringali et al
(2008)(19)
Hearing Aids
Chen et al
(2004)(3)
Deveze et al
(2010)(10)
Kraus et al
(2011)(4)
Type of
hearing loss
Severity of
hearing loss
Device type
N
Method of assessment
Speech reception
threshold gain
Unaided speech
reception threshold
Aided speech
reception threshold
SNHL
mild-severe
NR
5
NR
7dB
62dB
55dB
SNHL
mild-severe
Esteem SP
54
CD Spondee word list
28.3dB
58.9dB
30.6dB
MHL
moderate
NR
1
SRT50
20dB
-
-
SNHL
moderate-severe
NR
10
13dB
75dB
62dB
CHL
NR
NR
5
32dB
-
-
CHL
severe
NR
1
SRT 50% using
bisyllabic words
Freiburger speech
discrimination
SRT
29dB
75dB
46dB
SNHL
mild-severe
5
NR
23dB
62dB
39dB
MHL
moderate
patient’s
“best-fit”
patient’s own
1
SRT 50%
5dB
-
-
SNHL
mild-severe
patient’s
“walk-in”
57
CD Spondee word list
17.7dB
58.9dB
41.2dB
SRT: speech reception threshold, SNHL: sensorineural hearing loss, CHL: conductive hearing loss, MHL: mixed hearing loss, NR: not reported
Table D3. Speech recognition
Study
Esteem
Barbara et al
(2009)(1) & (2011)(2)
Chen et al (2004)(3)
Kraus et al (2011)(4)
Memari et al
(2011)(6)
Murali et al (2009)(7)
Carina
Bruschini et al
(2009)(8) & (2010)(9)
Type of
hearing loss
Severity of
hearing loss
Device
type
N
Method of assessment
Unaided speech
recognition (%)
Aided speech
recognition (%)
p-value
SNHL
Moderate
Severe
mild-severe
mild-severe
moderatesevere
NR
NR
NR
Esteem SP
NR
9
9
5
54
10
Speech discrimination @ 60dB
Speech discrimination @ 75dB
CID-W22 word list in quiet @ 50dB
Words @ 50dB
Speech discrimination
42
30
21
10.5
70.2
79
72
47
69.1
73.0
0.62
NR
3
Discrimination open set
Discrimination closed set
-
95
100
-
moderatesevere
moderate
NR
8
Disyllabic words @ 65dB
32.5
68.75
-
NR
1
Words @ 65dB
-
80
-
SNHL
moderatesevere
NR
20
Monaural words
Monaural phenomes
-
77
87
-
MHL
NR
6
Disyllabic words in French
-
63.33
-
NR
8
94
-
NR
6
Disyllabic Fournier or Spanish words @
65dB
Monosyllables
35
SNHL
moderatesevere
moderatesevere
NR
-
80
-
@ 40dB
@ 50dB
@ 60dB
@ 70dB
@ 40dB
@ 45dB
@ 50dB
@ 55dB
@ 60dB
@ 70dB
0
30
-
0
70
80
90
0
50
50
60
90
100
-
SNHL
SNHL
SNHL
SNHL
SNHL, MHL
Deveze et al
(2010)(10)
Jenkins et al
(2007)(11) &
(2008)(12)
Lefebvre et al
(2009)(13)
Martin et al
(2009)(14)
Neumann et al
(2010)(15)
Tringali et al
(2008)(19)
MHL
CHL
severe
NR
1
Tringali et al
(2009)(20)
MHL
severe
NR
1
SNHL
mild-severe
5
CID-W22 word list in quiet @ 50dB
21
76
MHL
moderate
patient’s
“best-fit”
patient’s
own
1
Words @ 65dB
-
40
Hearing Aids
Chen et al (2004)(3)
Deveze et al
(2010)(10)
MHL
-
-
Jenkins et al
(2007)(11) &
(2008)(12)
Kraus et al (2011)(4)
SNHL
moderatesevere
patient’s
own
20
Monaural words
Monaural phenomes
-
86
92
-
SNHL
mild-severe
patient’s
“walk-in”
54
Words @ 50dB
10.5
45
-
SNHL: sensorineural hearing loss, CHL: conductive hearing loss, MHL: mixed hearing loss, NR: not reported
Table D4. Quality of life
Study
Esteem
Barbara et al
(2011)(2)
Method of assessment
N
Results
Significance
Glasgow Benefit Inventory (improvement due to
intervention, score -100 to +100)
18
Moderate hearing loss: mean 11.12 (range
2.8-25)
Severe hearing loss: mean 6.83 (range 2.227.8)
Moderate hearing loss: mean 17.7 in
itinere, 20.6 final
Severe hearing loss: 18.1 in itinere, 18.2
final
EC
26
BN
24
AV
-12
RV
32
Overall Average
27
Clarity of sound
79
Speech in Noise
71
Natural voices
77
Understanding
67
conversations
Self confidence
81
Active lifestyle
87
NR
Degree of satisfaction is similar for moderate and
severe hearing loss. No statistical tests reported.
Client Oriented Scale of Improvement
(improvement in hearing due to intervention,
score 5 to 25)
Chen et al
(2004)(3)
Abbreviated Profile of Hearing Aid Benefit (%
benefit vs unaided, EC= ease of communication,
BN= background noise, AV=aversivenss,
RV=reverberation)
5
Kraus et al
(2011)(4)
QoL questionnaire (% of patients reporting the
device is equal or better than their hearing aid)
57
Abbreviated Profile of Hearing Aid Benefit
Maurer &
Savvas
(2010)(5)
Abbreviated Profile of Hearing Aid Benefit (%
benefit vs unaided, EC= ease of communication,
BN= background noise, AV=aversivenss,
RV=reverberation)
6
Memari et al
(2011)(6)
QoL questionnaire (compare sound quality with
the Esteem to conventional hearing aids)
10
Abbreviated Profile of Hearing Aid Benefit (%
difficulty experienced, EC= ease of
communication, BN= background noise,
AV=aversivenss, RV=reverberation)
8
Abbreviated Profile of Hearing Aid Benefit (%
difficulty experienced, EC= ease of
communication, BN= background noise,
20
Carina
Bruschini et al
(2009)(8) &
(2010)(9)
Jenkins et al
(2007)(11) &
(2008)(12)
EC
43
BN
53
AV
3
RV
40
Overall Average
38
4/10 improved, 5/10 the same, 1/10 worse
EC
BN
AV
RV
EC
BN
AV
Uniaded
54.08
66.08
4.33
78.33
22
37
-32
Aided
10.33
19.33
2
19.83
Benefit from the Esteem compared to hearing aids in
all categories. No statistical tests reported.
The majority of subjects considered the device to be
equal to or better than hearing aids. No statistical
tests reported.
Statistically significant increase in benefit in all
subcategories compared to hearing aids (p≤0.01)
Increased benefit over hearing aids in RV, BN, & AV.
No difference in EC. No statistical tests reported.
Majority of patients felt that sound quality was equal
to or improved with the Esteem compared to hearing
aids.
Less difficultly experienced in the aided compared to
the unaided condition in all subscales. No statistical
tests reported.
Patients experienced less difficulty with the Carina
than with hearing aids in all categories. No statistical
tests reported.
Lefebvre et al
(2009)(13)
AV=aversivenss, RV=reverberation)
Abbreviated Profile of Hearing Aid Benefit (%
difficulty experienced, EC= ease of
communication, BN= background noise,
AV=aversivenss, RV=reverberation)
RV
5
Martin et al
(2009)(14)
Abbreviated Profile of Hearing Aid Benefit (%
difficulty experienced, EC= ease of
communication, BN= background noise,
AV=aversivenss, RV=reverberation)
7
Rameh et al
(2010)(16)
Hearing Aids
Chen et al
(2004)(3)
QoL questionnaire
10
Abbreviated Profile of Hearing Aid Benefit (%
benefit vs unaided, EC= ease of communication,
BN= background noise, AV=aversivenss,
RV=reverberation)
5
Jenkins et al
(2007)(11) &
(2008)(12)
Abbreviated Profile of Hearing Aid Benefit (%
difficulty experienced, EC= ease of
communication, BN= background noise,
AV=aversivenss, RV=reverberation)
QoL questionnaire (% of patients reporting the
device is equal or better than their hearing aid)
20
Kraus et al
(2011)(4)
Maurer &
Savvas
(2010)(5)
35
Unaided Aided
EC
56.2
23
BN
48.6
35.2
AV
17.2
35.2
RV
46.2
35.6
Unaided Aided
EC
49.8
19.9
BN
45.3
44
AV
25.8
38.6
RV
57.7
44.8
29% of patients satisfied with device
Abbreviated Profile of Hearing Aid Benefit
EC
BN
AV
RV
Overall Average
BN
AV
RV
EC
BN
AV
RV
Clarity of sound
Speech in Noise
Natural voices
Understanding
conversations
Self confidence
Active lifestyle
NR
Abbreviated Profile of Hearing Aid Benefit (%
benefit vs unaided, EC= ease of communication,
BN= background noise, AV=aversivenss,
RV=reverberation)
Overall sound quality
Sound of own voice
Cleaning & maintenance
EC
43
BN
39
AV
-36
RV
35
57
6
27
30
-34
27
28
68
44
52
31
53
-37
48
79
71
77
67
Patients experienced less difficulty with the Carina
compared to unaided in EC, BN, & RV. Patients
experienced more aversiveness to sound with the
Carina than without. No statistical tests reported.
Statistically significant improvement in EC, RV & AV
with the Carina compared to the unaided condition
(P<0.05). No significant difference in BN.
Patients were more satisfied with the VSB compared
to the Carina. No statistical tests reported.
Benefit from the Esteem compared to hearing aids in
all categories. No statistical tests reported.
Patients experienced less difficulty with the Carina
than with hearing aids in all categories. No statistical
tests reported.
The majority of subjects considered the device to be
equal to or better than hearing aids. No statistical
tests reported.
81
87
Statistically significant increase in benefit in all
subcategories compared to hearing aids (p≤0.01)
19
22
55
Less benefit with hearing aids than Esteem in RV, BN,
& AV. No difference in EC. No statistical tests reported.
Overall Average
20
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